Background Large skull reconstruction, with the use of customized cranial implants, restores cerebral protection, physiologic homeostasis, and one's preoperative appearance. Cranial implants may be composed of either bone or a myriad of alloplastic biomaterials. Recently, patient-specific cranial implants have been fabricated using clear polymethylmethacrylate (PMMA), a visually transparent and sonolucent variant of standard opaque PMMA. Given the new enhanced diagnostic and therapeutic applications of clear PMMA, we present here a study evaluating all outcomes and complications in a consecutive patient series. Methods A single-surgeon, retrospective, 3-year study was conducted on all consecutive patients undergoing large cranioplasty with clear PMMA implants (2016–2019). Patients who received clear PMMA implants with embedded neurotechnologies were excluded due to confounding variables. All outcomes were analyzed in detail and compared with previous studies utilizing similar alloplastic implant materials. Results Fifty-five patients underwent cranioplasty with customized clear PMMA implants. Twenty-one (38%) were performed using a single-stage cranioplasty method (ie, craniectomy and cranioplasty performed during the same operation utilizing a prefabricated, oversized design and labor-intense, manual modification), whereas the remaining 34 (62%) underwent a standard, 2-stage reconstruction (craniectomy with a delayed surgery for cranioplasty and minimal-to-no implant modification necessary). The mean cranial defect size was 101.8 cm2. The mean follow-up time was 9 months (range, 1.5–39). Major complications requiring additional surgery occurred in 7 patients (13%) consisting of 2 (4%) cerebrospinal fluid leaks, 2 (4%) epidural hematomas, and 3 (4%) infections. In addition, 3 patients developed self-limiting or nonoperative complications including 2 (4%) with new onset seizures and 1 (2%) with delayed scalp healing. Conclusions This is the first reported consecutive case series of cranioplasty reconstruction using customized clear PMMA implants, demonstrating excellent results with regard to ease of use, safety, and complication rates well below published rates when compared with other alloplastic materials. Clear PMMA also provides additional benefits, such as visual transparency and sonolucency, which is material specific and unavailable with autologous bone. Although these early results are promising, further studies with multicenter investigations are well justified to evaluate long-term outcomes.
BACKGROUND Decompressive craniectomy is a lifesaving treatment for intractable intracranial hypertension. For patients who survive, a second surgery for cranial reconstruction (cranioplasty) is required. The effect of cranioplasty on intracranial pressure (ICP) is unknown. OBJECTIVE To integrate the recently Food and Drug Administration-approved, fully implantable, noninvasive ICP sensor within a customized cranial implant (CCI) for postoperative monitoring in patients at high risk for intracranial hypertension. METHODS A 16-yr-old female presented for cranioplasty 4-mo after decompressive hemicraniectomy for craniocerebral gunshot wound. Given the persistent transcranial herniation with concomitant subdural hygroma, there was concern for intracranial hypertension following cranioplasty. Thus, cranial reconstruction was performed utilizing a CCI with an integrated wireless ICP sensor, and noninvasive postoperative monitoring was performed. RESULTS Intermittent ICP measurements were obtained twice daily using a wireless, handheld monitor. The ICP ranged from 2 to 10 mmHg in the supine position and from −5 to 4 mmHg in the sitting position. Interestingly, an average of 7 mmHg difference was consistently noted between the sitting and supine measurements. CONCLUSION This first-in-human experience demonstrates several notable findings, including (1) newfound safety and efficacy of integrating a wireless ICP sensor within a CCI for perioperative neuromonitoring; (2) proven restoration of normal ICP postcranioplasty despite severe preoperative transcranial herniation; and (3) proven restoration of postural ICP adaptations following cranioplasty. To the best of our knowledge, this is the first case demonstrating these intriguing findings with the potential to fundamentally alter the paradigm of cranial reconstruction.
Introduction: Cranioplasty (CP) is a multifaceted procedure in a heterogenous patient population, with a high risk for complication. However, no previous large-scale studies have compared outcomes in primary (ie, first attempt) CP versus revision CP (ie, following previous attempts). The authors, therefore, analyzed long-term outcomes of 506 consecutive primary and revision CPs, performed by a single surgeon. Methods: All CPs performed between 2012 and 2019 were analyzed under IRB protocol approval. Surgeries were categorized as either primary (no previous CP; n = 279) or revision CP (at least one previous CP; n = 227). Complications were defined as either major or minor. Subgroup analyses investigated whether or not CP complication risk directly correlated with the number of previous neuro-cranial surgeries and/or CP attempts. Results: The primary CP group experienced a major complication rate of 9% (26/279). In comparison, the revision CP group demonstrated a major complication rate of 32% (73/227). For the revision CP group, the rate of major complications rose with each additional surgery, from 4% (1 prior surgery) to 17% (2 prior surgeries) to 39% (3–4 prior surgeries) to 47% (≥5 prior surgeries). Conclusion: In a review of 506 consecutive cases, patients undergoing revision CP had a 3-fold increase in incidence of major complications, as compared to those undergoing primary CP. These results provide critical insight into overall CP risk stratification and may guide preoperative risk-benefit discussions. Furthermore, these findings may support a center-of-excellence care model, particularly for those patients with a history of previous neuro-cranial surgeries and/or CP attempts.
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